7.2.1.3.6.1
17-Item HAMD
The
LOCF analyses showed p values of less than 0.05 favoring drug over placebo at
three, four, seven, and eight weeks for 150 mg/d and at eight weeks for 300
mg/d. the OC analysis showed p values
of less than 0.05 favoring drug over placebo at four weeks for 150 mg/d and at
no time for 300 mg/d. Had the sponsor
corrected their analysis for multiple-comparisons, no significant differences
would have been demonstrated at any time point. Fifty-five of 120 (46%) 150 mg/d patients, 52 of 113 (46%) 300
mg/d patients, and 41 of 117 (35%) placebo patients were considered treatment
responders at time of discontinuation.
A Pearson chi-square analysis comparing the proportion of responders
across the treatment groups showed no difference between the three treatment
groups (X2=3.78, df=2, p=0.151).
7.2.1.3.6.2
28-Item HAMD
The
LOCF analyses showed p values of less than 0.05 favoring drug over placebo at
three weeks for 150 mg/d and at no time for 300 mg/d. The OC analysis showed p values of less than 0.05 favoring drug
over placebo at four weeks for 150 mg/d and at no time for 300 mg/d. Had the sponsor corrected their analysis for
multiple-comparisons, no significant differences would have been demonstrated
at any time point. Fifty-four of 120
(45%) 150 mg/d patients, 54 of 113 (48%) 300 mg/d patients, and 39 of 117 (33%)
placebo patients were considered treatment responders at time of
discontinuation. A Pearson chi-square
analysis comparing the proportion of responders across the treatment groups
showed a trend toward one of the three groups being of different efficacy than
the others (X2=5.60, df=2, p=0.061).
7.2.1.3.6.3
HAMD-Item #1
The
LOCF analyses showed p values of less than 0.05 favoring drug over placebo at
seven weeks for 150 mg/d and at eight weeks for 400 mg/d. The OC analysis showed p values of less than
0.05 favoring drug over placebo at no time for either dosage. Had the sponsor corrected their analysis for
multiple-comparisons, no significant differences would have been demonstrated
at any time point.
7.2.1.3.6.4
CGI-S
The
LOCF analyses showed p values of 0.05 or less favoring drug over placebo at
three, four, five, seven, and eight weeks for 150 mg/d and at six and eight weeks
for 300 mg/d. The OC analyses showed p
values of 0.05 or less favoring drug over placebo at three through five weeks
for 150 mg/d and at no time for 300 mg/d.
Had the sponsor corrected their analysis for multiple-comparisons,
significant differences would have been demonstrated in the LOCF analysis at
four and seven weeks for 150 mg/d and in the OC analysis at four weeks for 150
mg/d, but not at any other time point on any other CGI-S analysis.
7.2.1.3.6.5
CGI-I
The
LOCF analyses showed p values of 0.05 or less favoring drug over placebo at
three through eight weeks for 150 mg/d and at six through eight weeks for 300
mg/d. The OC analysis showed p values
of less than 0.05 favoring drug over placebo at three through five weeks for
150 mg/d and at eight weeks for 300 mg/d.
Had the sponsor corrected their analysis for multiple-time point
comparisons, significant differences would have remained at four and eight
weeks for 150 mg/d and at eight weeks for 300 mg/d on the LOCF analysis, and at
four weeks at 150 mg/d on the OC analysis.
Fifty-eight of 120 (48%) 150 mg/d patients, 59 of 113 (52%) 300 mg/d
patients, and 42 of 116 (36%) placebo patients were considered treatment
responders at time of discontinuation.
A Pearson chi-square analysis comparing the proportion of responders
across the treatment groups showed at least one of the three groups being of
different efficacy than the others (X2=6.48, df=2, p=0.080) toward
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